Focus Group Study of Youth Reactions to Creative Advertising Concepts Designed to Reduce Tobacco Use among General Market Youth

OMB# 0910-0674 Exp: 3/31/2016

RETAIN FOR YOUR RECORDS

WAVE 2 PHASE 1 QUALITATIVE RESEARCH: GENERAL MARKET AT-RISK YOUTH TOBACCO PREVENTION FOCUS GROUPS YOUTH ASSENT FORM

Please read this form carefully. You can ask as many questions as you want. If there is anything you do not understand, we will be happy to answer your questions. You must sign this form before you can take part in the study.

Introduction: About this study

The purpose of this study is to understand what youth think about different kinds of messages and ideas designed to reduce youth tobacco use.

DraftFCB is an advertising company partnering with the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) to hold focus groups with youth nationwide. Youth participating in this study will view marketing ideas we have developed to prevent youth from using tobacco. We are interested in hearing your thoughts and opinions about these ideas. We will use your feedback to develop advertisements and messages that may prevent other youth from beginning to use tobacco products.

Your Role in This Study: What will I do during this study?

You will be one of a group of six youth participating in an in-person focus group. The focus group will take place in a research facility.

The study will take place on [DATE] at [RESEARCH FACILITY] for 90 minutes. The group leader will ask questions about images, ideas and tobacco use prevention messages. You and the other participants will be asked to share your thoughts and opinions in response to these questions.

Privacy: Who will see the information I provide during this study?

All participants will be asked to respect the privacy of the other focus group members. Everyone will be asked not to disclose anything said during the discussion.

Focus group discussions may be audiotaped and transcribed for reporting purposes. The report generated using this information will not link your comments directly to you or include your full name, and no one outside of the focus group participants and researchers will know what you said during the discussions. Only your first name will be used during the check-in process and during the discussions; your full name will not be shared with the group leader or other participants.

The audio files and transcripts will be stored on a password-protected computer and/or in locked cabinets that are only accessed by the research team. Although some personal information will be gathered (e.g., gender, age, race, thoughts, opinions and reactions to messages and ideas designed to prevent youth from using tobacco), no personal identifiers (e.g., full name, address, social security number) will be collected during the focus group discussion.

All personal information, including data collected during screening and the focus group discussion, will be destroyed three years after the completion of the study either by the shredding of documents or the permanent deletion of electronic information. 

All information you provide will be kept private to the extent allowable by law. This means that we will not share information with anyone outside of the study unless it is necessary to protect you, or if it is required by law. Information you share about your tobacco-related attitudes, beliefs and behaviors will not be shared with your parent(s) or guardian(s).

Anonymous data from this study may be published in professional journals or at scientific conferences, but no individual participant will be identified or linked to the results. We will not disclose your identity in any report or presentation.

Token of Appreciation: Will I be given a token of appreciation for being in this study?

Everyone who participates in this study will receive $50 as a token of our appreciation for being in this study.

Anticipated Benefits: What good comes from my participation?

This study is not expected to directly benefit you. However, your feedback will help us decide what ideas, images or messages may prevent youth tobacco use.

Anticipated Risks: Could anything bad happen to me during this study?

The risks for taking part in this study are low. You may have questions about tobacco use or tobacco use prevention before, during or after this study. You can ask the group leader any questions you have about this focus group. You can also talk to your parents or a teacher or school counselor.

If you have any questions about this research study, you may call Charlie Cook at DraftFCB (212-885-2987) or Tesfa Alexander at CTP (301-796-9335). Remember that you can stop participating in this study at any time.

Participation and Withdrawal: Do I have to be in this study? What if I want to stop participating?

This study is completely voluntary. You can stop participating at any time. You do not have to answer any questions you do not want to.

Research Questions and Contacts: Whom do I call if I have questions now or later?

If you have any questions about this research study, you may call Charlie Cook at DraftFCB (212-885-2987) or Tesfa Alexander at CTP (301-796-9335).

I have read and understand all of the information above. My questions have been answered and I would like to participate in this study.

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Printed Name of Youth Research Participant

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Signature of Youth Participant Date

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Signature of Investigator/Witness Date

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 5 minutes per response to complete the Youth Assent statement (the time estimated to read, review, and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.

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